CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 94 enrolled
Drug / intervention
Pelvic floor shear wave elastography +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07458737
NCT07458737N/ACompleted

Comparison of Superficial Pelvic Floor Shear Wave Elastography Between Healthy Women and Women With Pudendal Neuralgia

Comenius University·observational·Posted Mar 9, 2026·Updated Apr 2, 2026

In Brief

An observational study evaluating Pelvic floor shear wave elastography, Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7), and 1 other intervention for Pudendal Nerve and Healthy Women. Completed, enrolled 94 participants across 1 site.

Detailed Summary

This study will compare superficial pelvic floor shear-wave elastography between healthy women and women with pudendal neuralgia.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSlovakia

Timeline

N/ACompletedFinished
2026
First PostedMar 9, 2026
Enrollment StartMar 15, 2025
Primary CompletionFeb 25, 2026
Study CompletionMar 2, 2026
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4 months ago

Interventions

Pelvic floor shear wave elastographyother

Imaging was performed using a Consona N8 ultrasound system (Shenzhen Mindray Bio-Medical Electronics Co., Ltd.) equipped with shear-wave elastography (SWE) software. A linear-array transducer (L13-3N; frequency range 3.0-13.0 MHz; field of view \~3.8-4.0 cm) was used to obtain pelvic floor muscle (PFM) images. Measurements were performed using shell analysis by comparing two locations within the same pelvic floor muscle: the sites with the highest and lowest stiffness (kPa).

Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7)other

The PFIQ-7 is a 21-item questionnaire (three scales with seven items each) assessing the impact of pelvic floor disorders on daily life. Items are scored from 0 to 3, and the total score ranges from 0 to 300. Higher scores indicate greater impact/distress.

Female Sexual Distress Scale-Revised (FSDS-R)other

The FSDS-R is a 13-item questionnaire assessing sexually related personal distress in women, with a total score range of 0-52. Items are rated on a 5-point Likert scale (0 = never to 4 = always). Higher scores indicate greater sexual distress.